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Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that its upcoming conference call on its third quarter financial results will also provide some representative examples of data being collected from patients in its clinical trials for forms of macular degeneration. The Company has treated 13 patients thus far in its three ongoing trials for dry age-related macular degeneration (dry AMD) and Stargardt’s Disease (SMD) using human embryonic stem cell (hESC)-derived retinal pigment epithelial cells. The first two trials were initiated in July of 2011. The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the U.K.
Across the various clinical trial sites, with regular patient follow-up, no adverse safety issues relating to the transplanted cells have been observed. At up to 16 months following treatment, no hyperproliferation, tumorigenicity, ectopic tissue formation, or apparent rejection were observed in any of the 13 patients at any time. Detailed clinical and diagnostic laboratory assessments were performed at multiple post-transplantation evaluations. In addition to monitoring the safety of the transplanted cells, the clinicians have also been carefully assessing patients – on regular follow-up visits – for evidence of anatomical and functional integration of the RPE cells. The RPE layer plays a central role in the health and function of the photoreceptor layer. In treating various forms of macular degeneration, such as dry AMD and SMD, the goal of the company’s RPE cell therapy is for repair and replacement of those areas in the eye where the RPE layer has degraded with new cells, and in doing so, recapitulate the correct working environment around the photoreceptor layer. At a recent meeting of the various U.S. and U.K. surgeons leading the clinical trials, the Company and surgeons reviewed the data from various patients and discussed next steps and strategies for the existing trials and designs for future phase II and III studies.